Skip to main content
OpenTrials
Completed

NCT Number: NCT06795594

Effectiveness of Cheek Acupuncture Therapy for Pain Control After Cesarean Delivery

This study investigates whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and explores its mechanisms of action through a prospective randomized controlled clinical trial.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital, Capital Medical University

Beijing, 100730, China

About this study

Pain control after cesarean delivery, if inadequately managed, can impact the prognosis of the mother and the health of the infant. There is an urgent need to explore safer, more effective, and straightforward non-pharmacological adjunctive interventions to alleviate the pain associated with cesarean section. Cheek acupuncture therapy is a green micro-acupuncture treatment that has shown significant improvement in various types of pain and holds great potential for relieving perioperative pain. To practice the concept of perioperative acupuncture medicine, this study aims to investigate whether cheek acupuncture therapy can alleviate postoperative pain in cesarean section patients and to explore the mechanisms by which it exerts its effects, through a prospective randomized controlled clinical trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are classified as American Society of Anesthesiologists (ASA) physical status I to III.
  • Scheduled for elective cesarean delivery under spinal anesthesia.
  • Patients are aged between 19 to 45 years old.
  • Patients have provided written informed consent.

Exclusion criteria

  • Local skin infection at the acupuncture sites in the cheek area.
  • Cases where spinal anesthesia fails and general anesthesia is required.
  • Patients with conditions such as recurrent alcohol abuse, fever, convulsions, or cardiopulmonary failure.
  • Patients who have used opioid medications at least 6 months prior to surgery.
  • Patients who are unable to understand the consent form and study questionnaire, including those with cognitive impairments.
  • Patients with a history of psychiatric illness.

Treatment and study plan

cheek acupuncture

Procedure

Cheek Acupuncture

sufentanil 2 µg/kg + ondansetron 0.2 mg/kg

Drug

The patient-controlled analgesia (PCA) pump held a solution of 2 µg/kg sufentanil and 0.2 mg/kg ondansetron in 100 ml. It infused 2 ml/hour continuously, allowing patients to self-administer an extra 2 ml bolus every 15 minutes if needed. For inadequate pain control, diclofenac sodium suppositories were used as rescue analgesia, depending on individual pain assessments and the requirement for extra relief.

Primary outcomes

  1. Numeric Rating Scale (0-10) pain score during movement

    Time frame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment

    Numeric Rating Scale, this scale is a validated tool for measuring pain intensity, with scores ranging from 0 (no pain) to 10 (the most severe pain imaginable).The higher the score, the more severe the pain.

Secondary outcomes

  1. the proportion of patients with NRS pain score ≥ 6

    Time frame: 24 hours postoperatively, which is half an hour after the completion of the second cheek acupuncture treatment

    Assess the proportion of severe pain by calculating the ratio of NRS pain scores that are greater than or equal to 6.

  2. NRS pain score during movement

    Time frame: morning of the day of discharge (assessed up 7 days)

    Numeric Rating Scale, this scale is a validated tool for measuring pain intensity, with scores ranging from 0 (no pain) to 10 (the most severe pain imaginable).The higher the score, the more severe the pain.

  3. The Hospital Anxiety and Depression Scale (HADS)-A

    Time frame: morning of the day of discharge (assessed up 7 days)

    The Hospital Anxiety and Depression Scale (HADS)-A is a subscale of the HADS, which is a self-assessment questionnaire used to screen for symptoms of anxiety and depression in patients within a non-psychiatric hospital setting. The 'A' stands for Anxiety, and the HADS-A specifically measures the severity of anxiety symptoms. It consists of 7 items rated on a 4-point scale, with scores ranging from 0 to 21, where higher scores indicate greater anxiety.

  4. HADS-D score

    Time frame: morning of the day of discharge (assessed up 7 days)

    The Hospital Anxiety and Depression Scale (HADS)-D is a subscale of the HADS, which is designed to identify anxiety and depression in patients within hospital settings. The 'D' stands for Depression, and this subscale specifically assesses the severity of depressive symptoms. It includes 7 items rated on a 4-point scale, with scores ranging from 0 to 21, where higher scores indicate more severe depressive symptoms.

  5. ISI score

    Time frame: morning of the day of discharge (assessed up 7 days)

    The ISI-(0-28) refers to the Insomnia Severity Index, which is a self-administered questionnaire used to evaluate the severity of insomnia. It consists of 7 items scored on a 5-point Likert scale, ranging from 0 (no difficulty) to 4 (extreme difficulty). The total score ranges from 0 to 28, with higher scores indicating greater severity of insomnia.

  6. QoR15 score

    Time frame: morning of the day of discharge (assessed up 7 days)

    The QoR15 score is a measure used to assess the quality of recovery following surgery. It stands for "Quality of Recovery-15," and it is a 15-item questionnaire that evaluates various aspects of a patient's recovery, such as pain, nausea, vomiting, fatigue, and return to physical and cognitive function. The score ranges from 0 to 150, with a higher score indicating a better quality of recovery.

  7. HCRP

    Time frame: 48 hours postoperatively

    HCRP stands for High-Sensitivity C-Reactive Protein. It is a blood test that measures the levels of C-reactive protein (CRP), which is a marker of inflammation in the body. High-sensitivity CRP tests can detect low levels of CRP, making it a useful tool for monitoring inflammation, cardiovascular risk, and the effectiveness of treatments for various inflammatory conditions.

  8. Beta-endorphin

    Time frame: 48 hours postoperatively

    Beta-endorphin is an endogenous opioid peptide produced by the body, consisting of 31 amino acids. It is a natural painkiller and plays a role in reducing pain and stress. Beta-endorphin is released in response to stress, pain, or the use of opioids, and it contributes to the body's reward system and regulation of mood. It is also associated with the release of adrenaline during stress or intense physical activity.

  9. Postoperative adverse reactions

    Time frame: From date of randomization until the date of discharge, assessed up to 7 days

    Explore whether cheek acupuncture intervention increases postoperative adverse reactions, including dizziness, abdominal bloating, nausea, vomiting, fatigue and so on.

  10. Postoperative severe complications

    Time frame: From date of randomization until the date of discharge, assessed up to 7 days

    Postoperative severe complications, including pulmonary complications, heart failure, liver dysfunction, kidney dysfunction, coagulation function, SIRS (Systemic Inflammatory Response Syndrome), stroke, and so on.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

Cheek Acupuncture Therapy Vs. Standard Therapy for Pain Control After Elective Caesarean Section - a Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.